A new tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs, named has received marketing approval from the U.S. Food and Drug Administration (FDA).
Zontivity is the first in a new class of drug, called a protease-activated receptor-1 (PAR-1) antagonist, which reduces the risk of heart attack and stroke, by decreasing clot formation.
The approval follows a recommendation for its use by an FDA advisory panel that voted 10-1 in favor of the drug in January.
In a placebo-controlled clinical trial with over 25,000 participants, Zontivity, demonstrate its effectiveness, however, the approval had been delayed over over safety concerns due to serious and sometimes fatal bleeding in trial patients who received Zontivity
We can read ind FDA press release: “In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death. In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5 percent to 7.9 percent over a 3-year period – about 0.5 percent per year,” said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research.
Zontivity (vorapaxar) is manufactured by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
The drug’s prescribing information (label) includes a Boxed Warning to alert health care professionals about this risk.